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Instacoat EN Super IV

1 of 18 products in this brand
Instacoat™ EN Super IV is a fully formulated enteric coating system based on Methacrylic Acid and Ethyl Acrylate Co-polymer. It is recommended in the cases where phthalate esters such as CAP or HPMCP are not compatible or pose other problems. Typically, a weight gain of around 8% provides reproducible delayed release profiles. Three separate formulations are available which are suitable for either fully aqueous, hydro-alcoholic, or fully organic solvent seems. With respect to solvent systems, the formulations are not interchangeable

Functions: Coating System

    Knowde Enhanced TDS

    Identification & Functionality

    Pharma & Nutraceuticals Functions

    Coating System

    Technologies

    Pharmaceuticals & Nutraceuticals

    Product Families

    Pharmaceuticals & Nutraceuticals — Excipients

    Pharmaceutical Coatings

    Typical Constituents

    Aqueous solvent: Methacrylic Acid Co-polymer Type C; Plasticiser; Titanium Dioxide; Edible Pigments; Glidant, Alkaliser, Surfactant.

    Features & Benefits

    Features

    • Methacrylic Acid copolymers are the most widely used and accepted enteric polymers worldwide.

    • Development and production staff are familiar with process requirements.

    • Aqueous processing option.

    • Hydro-alcoholic or organic solvent processing options.

    • Multiple plasticisers available.

    • Low viscosity coating system.

    • Rapid dispersibility in chosen solvent.

    • Glidant is included.

    • Can be applied in a wide range of equipment designs and sizes from most manufacturers.

    Benefits

    • Absence of regulatory problems and delays.

    • Easy scale-up and production introduction.

    • Safer working environment.

    • Environmentally friendly.

    • Can be used with highly moisture sensitive APIs that cannot tolerate aqueous processing.

    • Flexibility to avoid specific incompatibilities.

    • Low atomisation pressure required.

    • Excellent tablet-to-tablet coating uniformity.

    • Smooth & glossy appearance.

    • Rapid suspension preparation.

    • Overcomes polymer tack issues and contributes to productivity gains.

    • Easy scale-up and transfer to different equipment types or manufacturing sites.

    • Suitable for batch and continuous processes.

    Applications & Uses

    Markets

    Healthcare & Pharma

    Applications

    Healthcare & Pharma — Drug Delivery & Care Solutions

    Oral

    Healthcare & Pharma — Pharmaceutical Manufacturing

    Excipients & Coatings

    Equipment / Accessories

    • Variable-speed mechanical stirrer

    • Mixing Vessel

    Regulatory & Compliance

    Regulatory Information

    All products are checked for the regulatory compliance of all ingredients in the target countries and market segments of sale. This determination is made at the time the initial formulation is established, based on customer-supplied information. If market countries and/or segments are extended once the formulation has been established, customers are encouraged to contact us to ensure that regulatory compliance is not compromised.

    Technical Details & Test Data

    Recommended Solvent System and Reconstitution Level

    • Purified Water at up to 20% w/w solids

    • IPA at up to 10% w/w solids

    • 90% IPA + 10% Purified Water at up to 10% solids

    Please note that different formulations are provided according to the chosen solvent system. The individual formulations are not interchangeable between solvents.

    Calculation of Instacoat™ EN Super IV and Solvent Quantities

    • INSTACOAT EN-SUPER IV (Aqueous): Determine the quantities of INSTACOAT EN-SUPER IV (20% w/w solids) and water required based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 8% wt. gain, weigh 88 g Instacoat and 352 g purified water at room temperature (includes 10% overage for losses)

    • INSTACOAT EN-SUPER IV (Organic): Determine the quantities of INSTACOAT EN- SUPER IV (10% w/w solids) and IPA required, based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 8% wt. gain, weigh 88 g Instacoat and 792 g IPA at room temperature (includes 10% overage for losses).

    • INSTACOAT EN-SUPER IV (Hydro-alcoholic): Determine the quantities of INSTACOAT EN-SUPER IV (10% w/w solids) and 90% IPA + 10% Purified Water required, based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 8% wt. gain, weigh 88 g Instacoat and 713 g IPA + 79 g Purified Water at room temperature (includes 10% overage for losses).

    Reconstitution Process

    INSTACOAT EN-SUPER IV (Aqueous)

    • Add the weighed quantity of water to a mixing vessel.
    • Using a mechanical stirrer, stir the purified water to form a vortex.
    • Add required quantity of Instacoat EN–Super IV to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instacoat has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.

     

    INSTACOAT EN-SUPER IV (Organic)

    • Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.
    • Using a mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.
    • Add required quantity of Instacoat EN–Super IV to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instacoat has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.


    INSTACOAT EN-SUPER IV (Hydro alcoholic)

    • Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.
    • Using a mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.
    • Add required quantity of Instacoat EN–Super IV to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Stir for 5 minutes and add the weighed quantity of Purified water. Reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
    Recommended Process Conditions
      Side-Vented
    (Fully Perforated) Pans    		 Conventional
    (Non Perforated) Pans
      Aqueous Organic Hydro-Alcoholic Aqueous Organic Hydro-Alcoholic
    Pan Diameter (inch) 24-60 12-36
    Tablet Load (kg) 10-300 0.5-50
    Weight Gain (%) 8-0 %
    Number of Guns 1-6 1
    Liquid Nozzle diameter (mm) 1.0-1.2
    Atomising Air Pressure (bar) 1.5-2.5
    Pattern Air Pressure To achieve maximum uniform bed coverage        
    Tablet Bed Temperature (°C) 33-36 30-33 32-35 33-36 30-33 32-35
    Inlet Air Temperature (°C) Set to achieve required product bed temperature
    Suspension Spray Rate Set to achieve required product bed temperature
    Inlet Air Volume Set to achieve required bed temperature
    Exhaust Air Volume To maintain slight negative pressure in pan
    Pan Speed Minimum for steady tablet flow through spray zone

    Tablet bed temperature offers the most effective way of controlling the coating process. Where this measurement is unavailable, exhaust temperature may be substituted. However, the relationship between the two measurements is complex and depends on several factors such as pan load, pan depression, pan design and airflow rate. Indicated exhaust temperature may be above or below the true bed temperature. It is recommended that the relationship between the two measurements is calibrated.